Gaze and Gait Training With rTMS
Gaze and Gait Training With Neuromodulation
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the feasibility of combining repetitive transcranial magnetic stimulation (rTMS), gaze and gait training to improve walking and balance in people with or without mild cognitive impairment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2027
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2023
CompletedFirst Posted
Study publicly available on registry
May 18, 2023
CompletedStudy Start
First participant enrolled
January 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
Study Completion
Last participant's last visit for all outcomes
September 1, 2028
May 6, 2026
February 1, 2026
1.7 years
March 20, 2023
May 1, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Change in Foot Placement Error from baseline 1
Foot position relative to stepping targets.
Beginning and end of Visit 1, an average of 8 hours
Change in VOR Gain from baseline 1
The amount of eye relative to head movement during active head rotations.
Beginning and end of Visit 1, an average of 8 hours
Change in Foot Placement Error from baseline 2
Foot position relative to stepping targets.
Beginning and end of Visit 2, an average of 8 hours
Change in VOR Gain from baseline 2
The amount of eye relative to head movement during active head rotations.
Beginning and end of Visit 2, an average of 8 hours
Secondary Outcomes (2)
Change in Timed Up and Go (TUG) from baseline 1
Beginning and end of Visit 1, an average of 8 hours
Change in Timed Up and Go (TUG) from baseline 2
Beginning and end of Visit 2, an average of 8 hours
Study Arms (2)
Real 10 Hz rTMS
ACTIVE COMPARATORParticipants will receive 1 hour of real rTMS followed by 1 hour of gaze and gait training.
sham rTMS
SHAM COMPARATORParticipants will receive 1 hour of sham rTMS followed by 1 hour of gaze and gait training.
Interventions
Subjects will practice stepping on virtual targets with real-time feedback of their foot position displayed on a screen while walking on a treadmill.
Subjects will perform gaze stabilization and gaze shifting exercise via a virtual reality headset.
Sham rTMS stimulation will produce discharge noise and vibration without stimulating the cerebral cortex.
10 Hz rTMS for 5 seconds over the frontal eye fields with 25 second intertrain interval for 10 trains (500 pulses) at 90% of the resting motor threshold,
Eligibility Criteria
You may qualify if:
- Age 18 - 80 years
- Capable of providing informed consent and complying to the experimental procedures
You may not qualify if:
- Significant gait difficulty requiring ambulatory aids
- Presence of implanted device such as a neurostimulator, cochlear implant or pacemaker
- History of epilepsy
- History of hearing issues
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julia Choi, Ph.D.
University of Florida
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2023
First Posted
May 18, 2023
Study Start (Estimated)
January 1, 2027
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
September 1, 2028
Last Updated
May 6, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share